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Active Not Recruiting
NCT07785869
Effects of a Topical Serum Solution on Hair Characteristics
Conditions: Hair Characteristics
Sex: Female
Ages: 35 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 190
Sponsor: Pacagen, Inc.
Location: Eurofins | CRL, Cosmetics LLC Piscataway New Jersey
Summary
The purpose of this study is to assess changes in the characteristics of scalp hair among healthy female participants with mild to moderate hair loss, classified as Ludwig Scale I-3 to II-2
Eligibility Criteria
Inclusion Criteria:
1. Participant is female between 35 and 70 years of age;
2. Participant has mild to moderate hair loss, classified as Ludwig Scale I-3 to II-2;
3. Participant agrees not to use any hair products other than those required by the protocol (tonic, lacquer, gel, foam, etc.) until the end of the study;
4. Participant agrees not to change their shampoo, conditioner, or shampooing frequency and maintain a consistent hairstyle for the duration of the study;
5. Participant is willing to use only their regular, neutral mascara on their eyelashes and stop use of any other products on them for the duration of the study;
6. Participant is willing to not substantially change their current diet, medications, multivitamins or supplement, or exercise routines for the duration of the study;
7. Participant is in generally good health;
8. Participant understands and has signed an Informed Consent Form in conformance with 21 CFR Part 50: "Protection of Human Participants."
Exclusion Criteria:
1. Participant is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
2. Participant wears a weave, extensions or dreadlocks or any other hairstyles that would interfere with the comb test;
3. Participant exhibits irritation, tattoos, sunburn, rashes, scratches, burn marks, scarring, etc. on the test site, which might interfere with evaluations of test results;
4. Participant is participating in another clinical study;
5. Participant has used Minoxidil, Finasteride or any topical and oral supplements or other therapies (such as light therapy) known to prevent or promote hair growth within the past 3 months;
6. Participant has been taking a stable dose of thyroid medication for a period of less than 4 months;
7. Participant has been taking a stable dose of GLP-1 (to manage diabetes or weight loss);
8. Participant has been taking a stable dose of hormonal medication (testosterone/ estrogen/progesterone) for a period of less than 6 months;
9. Participant has used any devices, prescriptions or OTC drugs that are known to affect the hair growth cycle within the past 6 months;
10. Participant uses medications known to affect the hair growth cycle within the last months such as cyproterone acetate, aldactone/spironolactone, finasteride, or other 5-alpha-reductase inhibitors;
11. Participant has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one month prior to initiation of the study;
12. Participant has a history of acute or chronic dermatologic, medical, and/or physical conditions which would, in the opinion of the Principal Investigator, could influence the outcome of the study;
13. Participant is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
14. Participant has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
15. Participant is currently undergoing treatment for active cancer of any kind;
16. Participant has uncontrolled diabetes.
Source: ClinicalTrials.gov (NCT07785869). StuddyBuddy aggregates publicly available trial information.